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The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma (EC-01)

This study is currently recruiting participants.
Verified October 2017 by Ding Ma, Huazhong University of Science and Technology
Sponsor:
ClinicalTrials.gov Identifier:
NCT01820858
First Posted: March 29, 2013
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Shandong University
Huazhong University of Science and Technology
Zhejiang University
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology
  Purpose
This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.

Condition Intervention Phase
Endometrial Neoplasms Drug: Paclitaxel Drug: Paraplatin (Carboplatin Injection) Radiation: Pelvic Radiation Radiation: Vaginal Brachytherapy 1 Radiation: Vaginal brachytherapy 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

Further study details as provided by Ding Ma, Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: 3-year DFS ]

Secondary Outcome Measures:
  • Side effect of adjuvant chemotherapy [ Time Frame: 3-month,6-month,1-year and 3-year ]
    The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis)

  • Complications of radiotherapy [ Time Frame: 3-month,6-month,1-year and 3-year ]
    To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.

  • Quality of Life [ Time Frame: 3-month,6-month,1-year and 3-year ]
  • Overall survival (OS) [ Time Frame: 3-year OS ]

Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adjuvant Chemotherapy
Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.
Drug: Paclitaxel
175 mg/m(2), intravenously (IV)
Drug: Paraplatin (Carboplatin Injection)
AUC=5, IV
Active Comparator: Adjuvant Radiotherapy
  1. Histopathological grade G3 and <50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times;
  2. Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy;
  3. ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.
Radiation: Pelvic Radiation
45-50 Gy
Radiation: Vaginal Brachytherapy 1
5 Gy, 3 times
Radiation: Vaginal brachytherapy 2
5 Gy, 2-4 times

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FIGO stage: Ⅰ, endometrial carcinoma;
  • Female, Chinese women;
  • Initial treatment is staging surgery;
  • Pathological diagnosis: Endometrial adenocarcinoma;
  • Pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement;
  • No prior treatment;
  • Provide written informed consent.

Exclusion Criteria:

  • Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
  • Family history of ovarian cancer;
  • Suffering from other malignancies;
  • Concurrently participating in other clinical trials;
  • Unable or unwilling to sign informed consents;
  • Unable or unwilling to abide by protocol.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820858


Contacts
Contact: Danhui Weng, MD, PhD +862783662681 weng.dh@gmail.com

Locations
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Danhui Weng, MD    +862783662681    weng.dh@gmail.com   
Principal Investigator: Changyu Wang, MD         
China, Shandong
Qilu Hospital,Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Xingsheng Yang, MD, Ph D    13791123129    xingshengyang@yahoo.com   
Principal Investigator: Xingsheng Yang, MD         
China, Zhejiang
Women's Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Yuyan Mao, MD    13989816955    maoyy3@yahoo.com.cn   
Principal Investigator: Yuyan Mao, MD         
Sponsors and Collaborators
Ding Ma
Shandong University
Huazhong University of Science and Technology
Zhejiang University
Investigators
Study Chair: Beihua Kong, MD, PhD Qilu Hospital, Shandong University
  More Information

Responsible Party: Ding Ma, Director of the department of Obstetrics and Gynecology, Tongji Hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01820858     History of Changes
Other Study ID Numbers: 2012-GYN/EC-01
First Submitted: March 20, 2013
First Posted: March 29, 2013
Last Update Posted: October 10, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action